Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Immutep reports positive Phase 1 results for IMP761 in autoimmune diseases

Immutep (ASX: IMM; NASDAQ: IMMP) has announced positive Phase 1 results for IMP761, a first-in-class LAG-3 agonist antibody designed to potentially supress pathogenic T cell responses in autoimmune diseases. According...

March 19, 2026

Developments

Niagen increases share repurchase program to $20 million

Niagen Bioscience (NASDAQ: NAGE) has announced that its board of directors has authorized an increase to the company’s previously disclosed share repurchase program, raising the total authorization from $10 million to...

March 19, 2026

Developments

Picard / SynCardia’s Total Artificial Heart enables four-year bridge to transplant

Picard Medical (NYSE American: PMI) has announced that a 29-year-old patient successfully received a donor heart transplant after more than four years of being fully supported by the SynCardia Total Artificial...

March 17, 2026

Developments

Trial finds Profound’s TULSA Procedure significantly improves erectile function and continence vs. robotic radical prostatectomy

Profound Medical (NASDAQ: PROF; TSX: PRN) has announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure with robotic...

March 16, 2026

Developments

Firefly announces discovery of new brain wave biomarkers for differential diagnosis of ADHD

Firefly Neuroscience (NASDAQ: AIFF) has announced advancements in research using resting EEG/cognitive EEG (ERP) brain scans, collected on its FDA 510(k)-cleared Evoke System, to potentially distinguish among the three...

March 13, 2026

Developments

REGENXBIO reports positive data from Phase 1/2 trial of RGX-202 in DMD

REGENXBIO (NASDAQ: RGNX) has announced new positive interim data from the Phase 1/2 AFFINITY DUCHENNE trial of RGX-202—a potential best-in-class therapy for Duchenne muscular dystrophy (DMD). Trial investigator Carolina...

March 11, 2026

Developments

Clearmind advances recruitment for third cohort of CMND-100 trial at leading sites

Clearmind Medicine (NASDAQ: CMND) has announced the continuation of participant enrollment for the third cohort of its ongoing FDA-approved Phase 1/2a trial evaluating CMND-100, its proprietary non-hallucinogenic MEAI...

March 11, 2026

Developments

bioAffinity initiates longitudinal study for CyPath Lung

bioAffinity Technologies (NASDAQ: BIAF; BIAFW) has initiated a planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer. The 2,000...

March 11, 2026

Developments

ACCP Journal publishes PK studies of Tonix’s TONMYA in fibromyalgia

Tonix Pharmaceuticals (NASDAQ: TNXP) has announced that the American College of Clinical Pharmacology (ACCP) journal Clinical Pharmacology in Drug Development published results from clinical pharmacokinetic (PK) studies...

March 6, 2026

Developments

Volition announces first ever automated Nu.Q Vet Cancer Test

VolitionRx (NYSE American: VNRX) has announced the completion of all validation and verification of the chemiluminescent immunoassay (ChLIA) version of its Nu.Q Vet Cancer Test with closely held Fujifilm Vet Systems Co...

March 6, 2026

Developments

INOVIO and Akeso collaborate to advance GMB therapy

INOVIO (NASDAQ: INO) and Akeso (HKEX: 9926) have announced a clinical trial collaboration and supply agreement to evaluate INO-5412, INOVIO’s DNA immunotherapy candidate, in combination with cadonilimab...

March 4, 2026

Developments

Firefly nears launch of NVIDIA-powered human brain model

Firefly Neuroscience (NASDAQ: AIFF) has announced a greater than 20-fold expansion of its commercial footprint, and a 33-fold Increase in its EEG/ERP scan volumes. Through its acquisition of closely held Evoke...

March 4, 2026

Developments

FDA approves Perimeter’s Claire, first AI imaging device for breast cancer surgery

Perimeter Medical Imaging AI (TSXV: PINK; OTCQX: PYNKF) has announced that it has received FDA premarket approval (PMA) for Claire—formerly the Perimeter OCT B-Series with ImgAssist AI 2.0—the first AI-enabled imaging...

March 3, 2026

Developments

Psyence ships GMP-compliant psilocybin to Australia for Phase 2b trial

Psyence BioMed (NASDAQ: PBM) has announced the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia for the ongoing Phase 2b clinical trial evaluating natural psilocybin for the treatment of...

March 3, 2026

Developments

Rein doses first patient in Phase 2 trial of LTI-03 in IPF

Rein Therapeutics (NASDAQ: RNTX) has announced that the first patient has been dosed in its Phase 2 clinical trial evaluating LTI-03 for idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease with...

March 3, 2026

Developments

AIM signs Phase 3 design deal for Ampligen in pancreatic cancer

AIM ImmunoTech (NYSE American: AIM) has announced the signing of an agreement with Thermo Fisher Scientific’s (NYSE: TMO) PPD clinical research business to design its Phase 3 clinical trial for Ampligen in the treatment...

March 2, 2026

Developments

Zomedica expands distribution with Moichor partnership

Zomedica (OTCQB: ZOMDF) has entered into a commercial distribution agreement with closely held Moichor, a veterinary reference and point-of-care laboratory service, to expand its distribution of TRUVIEW(R) digital...

February 25, 2026

Developments

Tiziana announces positive new biomarkers for nasal foralumab

Tiziana Life Sciences (NASDAQ: TLSA) has announced new biomarker data from a late-breaking poster presented by investigators from Brigham and Women’s Hospital, Boston, showing nasal foralumab downregulates cerebrospinal...

February 25, 2026

Developments

FDA grants QIDP for Armata’s AP-SA02

Armata Pharmaceuticals (NYSE American: ARMP) has announced that the FDA has granted AP-SA02 Qualified Infectious Disease Product (QIDP) designation for intravenous use in the adjunct treatment of complicated bacteremia...

February 23, 2026

Developments

C4 doses first patient in Phase 2 trial of cemsidomide in RRMM

C4 Therapeutics (NASDAQ: CCCC) has announced that the first patient has been dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone for the treatment of relapsed/refractory multiple...

February 23, 2026

Developments

Acrivon launches internal CLIA-certified lab

Acrivon Therapeutics (NASDAQ: ACRV) has announced the completion and certification of its internal, wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory, located on premises in...

February 18, 2026

Developments

Lipocine Completes Last Patient Last Visit in Pivotal Phase 3 Trial of LPCN 1154 for Postpartum Depression

Lipocine (NASDAQ: LPCN) has announced that the last patient has completed the final study visit in the Phase 3 trial of its oral brexanolon, LPCN 1154, for the treatment of postpartum depression (PPD). According to...

February 18, 2026

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